CDSCO cosmetic product registration cancelled: what this case teaches manufacturers
On May 20, 2025, the Central Drugs Standard Control Organisation (CDSCO), India’s national authority for drugs and cosmetics, cancelled the registration of several imported cosmetic products. The decision followed the discovery of salicylic acid concentrations that exceeded the limits allowed under national regulations.
Although the cancellation applied to a specific set of products, the case underscores a critical message for all manufacturers aiming to sell in foreign markets: complying with local requirements is not optional. It is essential for maintaining market access and protecting business continuity.
CDSCO’s decision and the applicable regulatory framework
According to the CDSCO, the affected products contained levels of salicylic acid that violated Rule 39 of the Cosmetics Rules, 2020. This regulation sets precise limits: 2% for leave-on products and 3% for rinse-off products.
In some cases, the concentration reached up to 30%, far exceeding the permitted thresholds. As a result, the registration was cancelled, and the importer was instructed to withdraw the products from the Indian market.
India’s regulatory system leaves little room for ambiguity. Products that do not meet the required safety and quality standards cannot be imported or sold. Rule 39 plays a central role in ensuring compliance and protecting public health, particularly by restricting ingredients considered potentially harmful at certain concentrations.
Why this case should matter to European and global manufacturers
Even though this situation involved a limited number of products, its implications extend far beyond India. Around the world, regulatory authorities are increasing their focus on enforcement and oversight, applying technical standards more strictly and consistently.
A minor formulation error or an outdated assumption about ingredient limits can lead to denied market access, forced product withdrawals, reputational damage and lost commercial opportunities. A registration certificate or approval is only part of the picture. Companies need to understand the local context and stay aligned with every market’s evolving requirements.
For European and non-EU manufacturers looking to expand into Asia, India represents both a key opportunity and a complex regulatory environment. In such markets, working with specialised partners is not just helpful — it is often essential to avoid regulatory missteps.
A practical reminder for regulatory affairs and quality teams
This case highlights the importance of maintaining up-to-date technical documentation, verifying formulations and staying informed on national restrictions. A product that is considered safe and compliant in one jurisdiction may not meet the standards of another, simply due to differences in local laws and accepted thresholds.
For professionals in regulatory affairs, compliance or quality assurance, cases like this are a valuable opportunity to review internal processes, update technical files and reassess strategies for entering or maintaining presence in international markets.
Staying informed helps prevent avoidable risks
The global regulatory landscape is constantly shifting. What is compliant today may fall outside the rules tomorrow. This applies not only to cosmetics, but also to medical devices and IVDs. The only way to protect your product and your business is to invest in knowledge, proactive monitoring and qualified support.
International regulations evolve quickly, but you don’t have to manage them alone.
With the right guidance, companies can approach compliance with confidence, minimise risk and unlock new opportunities for growth.
📩 If you want tailored support to navigate compliance challenges in global markets, feel free to reach out. Our team is here to help.
